ALBURX (albumin- human solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)

Tilgjengelig fra:

CSL Behring AG

INN (International Name):

ALBUMIN HUMAN

Sammensetning:

ALBUMIN HUMAN 12.5 g in 250 mL

Administreringsrute:

INTRAVENOUS

Indikasjoner:

The definitive treatment of major hemorrhage is the transfusion of red blood cells restoring a normal oxygen transport capacity of the blood. Since, however, the life-threatening event in major hemorrhage is the loss of blood volume and not the erythrocyte deficit, the blood volume can, as an emergency measure, be supported by ALBURX® 5, Albumin (Human) 5% solution or another rapidly acting plasma substitute if blood is not immediately available. This will restore cardiac output and abolish circulatory failure with tissue anoxia. Though a four- to fivefold volume of crystalloids may be equally effective, their administration takes more time and creates a general overload with sodium and water. In the presence of dehydration, electrolyte solutions such as Ringer's lactate should be administered in conjunction with albumin. Apart from damage to the respiratory tract, the development of burn shock is the most life-threatening event in the immediate care of the burned patient. Therapy during the first 24 hours i

Produkt oppsummering:

ALBURX® 5 is supplied as a 5% solution (50 g/L). Each product presentation includes a package insert and the following components listed in Table 1 below.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

ALBURX- ALBUMIN (HUMAN) SOLUTION
CSL BEHRING AG
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ALBUMIN (HUMAN) 5% SOLUTION
ALBURX 5
R ONLY
DESCRIPTION
ALBURX 5, Albumin (Human) 5% solution is a sterile aqueous solution
for intravenous
administration containing the albumin component of human blood. The
solution is clear
and slightly viscous; it is almost colorless, or yellow, amber, or
green.
This product is prepared from the plasma of US donors. The product has
been
produced by alcohol fractionation and has been heated for 10 hours at
60°C for
inactivation of infectious agents. The results of virus validation
studies have shown that
the manufacturing process, particularly alcohol fractionation,
eliminates enveloped and
non-enveloped viruses. Additionally, heat treatment at 60°C for a
period of 10 hours
efficiently inactivates viruses. The solution contains 0.14 M (3.2
mg/mL) sodium. The
aluminum content is ≤ 200 mcg/L and the potassium content is ≤
0.002 M. The solution
is stabilized with 0.004 M sodium N-acetyltryptophanate and 0.004 M
sodium caprylate.
The solution contains no preservative.
CLINICAL PHARMACOLOGY
ALBURX 5, Albumin (Human) 5% solution should not be used as an
intravenous
nutrient because of the slow breakdown and relatively unfavorable
composition of the
albumin molecule with respect to its content of essential amino acids.
Oral provision of
proteins or an intravenous regimen providing adequate calories and a
suitable amino
acid mixture are the methods of choice for the treatment of protein
malnutrition as
such, though they do not permit the rapid correction of
hypoproteinemia.
The binding properties of albumin may, in special circumstances,
provide an indication
for its clinical use. For such purposes, however, an Albumin (Human)
25% solution
should be used.
The colloid osmotic or oncotic properties of albumin constitute the
predominant reason
for its clinical use. The rationale for this is the Starling concept
of the capillary balance of
hydrostatic and oncotic pressure gradients across the capillary walls
as the determinan